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SMC rejects Amgen's Repatha over lack of outcomes data

But gives GlaxoSmithKline’s asthma drug Nucala the green light
Amgen Repatha

The Scottish Medicines Consortium (SMC) has turned down Amgen's cholesterol-lowering treatment Repatha (evolucumab), citing a lack of “robust” data.

The health technology assessment body said last week that insufficient clinical evidence - namely for long-term cardiovascular outcomes - was presented, making the drug's high price tag not cost-effective.

The first-in-class PCSK9 inhibitor works to reduce low-density lipoprotein cholesterol (LDL-C) in the blood, and serves as an alternative option to statin treatment.

Amgen's biologic has faced opposition over its high cost and lack of cardiovascular data before, though NICE - the SMC's counterpart in England and Wales - was persuaded to back Repatha earlier this year.

That recommendation followed a deal between the Department of Health and Amgen for a discount on the drug for NHS England.

Repatha was approved in Europe last year to treat patients with uncontrolled cholesterol who require additional intensive therapy to meet LDL-c targets, including for use in combination with statins.

GSK's Nucala receives restricted recommendation
Meanwhile, there was somewhat better news for GlaxoSmithKline as the SMC accepted its severe asthma therapy Nucala (mepolizumab) - albeit for restricted use - within NHS Scotland.

The drug was reviewed for its use as an add-on treatment for severe refractory eosinophilic asthma in adult patients, for which it was approved in Europe late last year.

But the SMC ruled that for patients to be eligible for Nucala treatment they would need to have eosinophils of at least 150 cells per microlitre and have had at least four asthma exacerbations in the preceding year, or be receiving maintenance treatment with oral corticosteroids.

The drug's go-ahead in Scotland is also contingent upon its availability through the country's Patient Access Scheme (PAS) to improve its cost-effectiveness.

Article by
Rebecca Clifford

20th June 2016

From: Regulatory



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